Pre-Conference Workshop Day
Tuesday, March 11, 2025

9:00 am Check-In, Coffee & Light Breakfast

Analytical Development Track

10:00am Workshop A

Leveraging AI for Enhanced Potency Assay Development in Cell Therapies

Synopsis

  • Identifying AI-driven solutions to address bottlenecks in current assay development workflows that hinder effective potency measurement
  • Exploring AI methodologies to optimize assay design and execution for improved consistency and reliability
  • Engaging audience participation through interactive discussions and hands-on activities to apply AI concepts in real-world assay development scenarios

Quality Control Track

10:00am Workshop B

Assessing Cell Line Selection Criteria to Ensure Robustness & Relevance in Potency Assays

Synopsis

  • Identifying critical factors in choosing a target cell line for potency assays
  • Evaluating how companies balance biological relevance with assay practicality
  • Reviewing methods to mitigate risks associated with inappropriate cell line selection

12:30 pm Lunch Break

1:30pm Workshop C

Vector Potency Assay Development & Implementation to Enhance Autologous Cell Therapy Manufacturing Success

  • Connie Tsai Associate Director - Analytical Development, Novartis

Synopsis

  • Highlighting the increased regulatory expectation and the importance of robust viral vector quality control strategy to enhance cell therapy manufacturing success
  • Potency assay for viral vector vs autologous cell therapy final product
  • Discuss common challenges and present case studies on the development of fit-for purpose vector potency assays

1:30pm Workshop D

Developing Quality Control-Friendly Potency Assays to Streamline Testing Processes

  • Kelly Bowen Associate Principal Scientist - Analytical Development, Technical Operations, KSQ Therapeutics

Synopsis

  • Exploring best practices for simplifying potency assays to fit quality control requirements
  • Identifying ways to reduce reliance on complex tests like flow cytometry
  • Reviewing quality control-friendly technologies to streamline potency testing workflows

4:00 pm End of Workshop Day